Monograph Title | Section | Source Publication | Page Number | Errata Post Date Sort ascending | Errata Official Date | Target Errata Print Publication | Target Online Fix Publication | Description |
---|---|---|---|---|---|---|---|---|
STERILE WATER FOR INHALATION | CHEMICAL INFORMATION | USP37–NF32 | 5174 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Add the chemical formula and molecular weight: H2O 18.02 |
STERILE WATER FOR IRRIGATION | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP37–NF32 | 5175 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Add: USP 1,4-Benzoquinone RS AND USP Sucrose RS |
ETHYLCELLULOSE DISPERSION TYPE B | ASSAY/Procedure | USP37–NF32 | 5981 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 3 of Analysis: Change Calculate the percentage of ethylcellulose in the portion of Ethylcellulose Dispersion Type B taken: to: Calculate the percentage of the labeled amount of ethylcellulose in the portion of Ethylcellulose Dispersion Type B taken: |
CALCIUM GLUCONATE INJECTION | Identification | USP37–NF32 | 2089 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1 of Identification test A: Change A volume of Injection diluted, if necessary, with water to obtain a test solution of calcium gluconate (1 in 100) responds to Identification test B under Calcium Gluconate. to: Dissolve a quantity of it in water to… Read More |
IRINOTECAN HYDROCHLORIDE INJECTION | IMPURITIES/Organic Impurities | USP37–NF32 | 3403 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Row 3 of Column 1 of Table 2: Change Camptothecinb to: Camptothecinb,d AND Row 5 of Column 1: Change 7-Ethylcamptothecinc to: 7-Ethylcamptothecinc,d AND Add a footnote: dThese process impuritiesare… Read More |
WATER FOR HEMODIALYSIS | CHEMICAL INFORMATION | USP37–NF32 | 5173 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Add the chemical formula and molecular weight: H2O 18.02 |
STERILE WATER FOR INJECTION | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP37–NF32 | 5175 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Add: USP 1,4-Benzoquinone RS AND USP Sucrose RS |
CELLACEFATE | ASSAY/Content of Acetyl | USP37–NF32 | 5919 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 12 of Analysis: Result = {[(P − 0.5182 × B)/(100 − B)] − (0.5772 × C)} × 100 to: Result = 100 × [P − (0.5182 × B)]/(100 − B) − (0.5772 × C) |
DACARBAZINE FOR INJECTION | IMPURITIES/Limit of 2-Azahypoxanthine | Second Supplement to USP37–NF32 | Online | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 2 of Analysis: Change 2-azahypoxanthine monohydrate to: 2-azahypoxanthine |
DIDANOSINE DELAYED-RELEASE CAPSULES | PERFORMANCE TESTS/Dissolution <711>/Analysis | USP37–NF32 | 2603 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 11 of the variable definition list: Change CS = concentration of didanosine in the Standard solution (mg/mL) to: CS = concentration of USP Didanosine Related Compound A RS in the Standard solution for the Acid stage or… Read More |
OXYBUTYNIN CHLORIDE | SPECIFIC TESTS/Loss on Drying <731> | USP37–NF32 | 4129 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1 of Acceptance criteria: Change NMT 3.0% to: NMT 3% |
STERILE WATER FOR INHALATION | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | USP37–NF32 | 5174 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Add: USP 1,4-Benzoquinone RS AND USP Sucrose RS |
PURE STEAM | CHEMICAL INFORMATION | USP37–NF32 | 5176 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Add the chemical formula and molecular weight: H2O 18.02 |
CHLORPHENIRAMINE MALEATE | IMPURITIES/Organic Impurities | First Supplement to USP37–NF32 | 6617 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1 of Standard solution: Change 1.1 μg/mL of USP Chlorpheniramine Maleate RS in Diluent, to: 1.4 μg/mL of USP Chlorpheniramine Maleate RS in Diluent, |
DACARBAZINE | USP Reference standards <11> | USP37–NF32 | 2504 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 3 of USP Dacarbazine Related Compound B RS: Change C4H3N5O 137.10 to: C4H3N5O · H2O 155.12 |
KETOPROFEN EXTENDED-RELEASE CAPSULES | ASSAY/Procedure/System suitability/Suitability requirements | USP37–NF32 | 3469 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1 of Tailing factor: Change NLT 1.5 to: NMT 1.5 |
WATER FOR INJECTION | CHEMICAL INFORMATION | USP37–NF32 | 5173 | 26-Sep-2014 | 1-Oct-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Add the chemical formula and molecular weight: H2O 18.02 |
TICLOPIDINE HYDROCHLORIDE | IMPURITIES | USP37–NF32 | 4958 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Change Residue on Ignition <231> to: Residue on Ignition <281> |
ATROPINE SULFATE | ASSAY/Procedure/System suitability/Suitability requirements | First Supplement to USP37–NF32 | 6591 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1of Relative standard deviation: Change NMT 1.0 to: NMT 1.0% |
<795> PHARMACEUTICAL COMPOUNDING—NONSTERILE PREPARATIONS | DEFINITIONS | USP37–NF32 | 403 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1 of Beyond-Use Date (BUD): Change The date after which a compounded preparation should not to be used; to: The date after which a compounded preparation shall not be used; |
TERBINAFINE HYDROCHLORIDE | IMPURITIES | First Supplement to USP37–NF32 | 6704 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Footnotes b, c, and d of Table 2: Change btrans-Isoterbinafine or (E)-N,6,6-trimethyl-N-(naphthalen-2-ylmethyl)hept-2-en-4-yn-1-amine. ccis-Terbinafine or (Z)-N,6,6-trimethyl-N-(naphthalen-1-ylmethyl)hept-2-… Read More |
CEFAZOLIN INJECTION | Assay | USP37–NF32 | 2190 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Change pH 3.6 Buffer, pH 7.0 Buffer, Mobile phase, Internal standard solution, Standard preparation, and Chromatographic system—Prepare as directed in the Assay under Cefazolin. to: pH 3.6 Buffer—Dissolve 0.900 g of anhydrous… Read More |
CLOPIDOGREL BISULFATE | ASSAY/Procedure | USP37–NF32 | 2422 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1 of System suitability solution: Change 25 µg/mL of USP Clopidogrel Bisulfate RS and 50 µg/mL of USP Clopidogrel Related Compound B RS to: 2.5 µg/mL of USP Clopidogrel Bisulfate RS and 5.0 µg/mL of USP Clopidogrel Related Compound B RS |
FLAVOXATE HYDROCHLORIDE | IMPURITIES | USP37–NF32 | 2988 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Row 3 of Column 1 of Impurity Table 1: Change Flavoxate related compound Aa,* to: Flavoxate related compound Aa AND Row 4 of Column 1 of Impurity Table 1: Change Flavoxate related compound Bb,* to: Flavoxate related compound B… Read More |
MITOTANE TABLETS | Assay | USP37–NF32 | 3858 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1 of Procedure: Change Proceed as directed in the Assay under Mitotane, beginning with “Concomitantly determine the absorbances of both solutions.” to: Concomitantly determine the absorbances of the Assay preparation and the Standard preparation… Read More |
GELATIN | SPECIFIC TESTS/Sulfur Dioxide/Analysis | USP37–NF32 | 5995 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 5 of the variable definition list: Change m = actual molarity of the Titrant (mol/mL) to: m = actual molarity of the Titrant (mol/L) |
INSULIN ASPART | IDENTIFICATION/B. Physicochemical Analytical Procedures for Insulins, Peptide Mapping <121.1>/Chromatographic system | First Supplement to USP37–NF32 | 6647 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1 of Column: Change 4.0-mm × 25-cm; 5-µm packing L7 to: 4.6-mm × 10-cm; 3-μm packing L1 |
AMIFOSTINE | ASSAY/Procedure/System suitability/Suitability requirements | USP37–NF32 | 1717 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1 of Column efficiency: Change NLT 100 to: NLT 1000 |
TIZANIDINE TABLETS | ASSAY/Procedure/System suitability | Second Supplement to USP37–NF32 | Online | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Change Sample: Standard solution to: Samples: System suitability solution and Standard solution AND Change Resolution: NLT 4.0 between tizanidine and tizanidine related compound C; NLT 4.0 between tizanidine and tizanidine related compound… Read More |
CEFUROXIME FOR INJECTION | Constituted solution | USP37–NF32 | 2246 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 3: Change meets the requirements for Constituted Solutions under Labeling under Injections <1>. to: meets the requirements for Constituted Solutions under Injections <1>. |
DULOXETINE DELAYED-RELEASE CAPSULES | IDENTIFICATION | USP37–NF32 | 2743 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Change A. Infrared Absorption <197S> to: A. Infrared Absorption <197F> |
LEVODOPA | IMPURITIES | USP37–NF32 | 3533 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Row 6 of Column 1 of Table 1: Change 1-Veratrylglycine to: L-Veratrylglycinea AND Add a footnote: a3-(3,4-Dimethoxyphenyl)-L-alanine. |
VINBLASTINE SULFATE | IDENTIFICATION/B. | USP37–NF32 | 5150 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1 of Sample: Change 100 mg/mL in water to: 10 mg/mL in water |
CEFADROXIL | ASSAY/Procedure | First Supplement to USP37–NF32 | 6602 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 3 of Sample solution: Change USP Cefadroxil RS to: Cefadroxil |
<1788> METHODS FOR THE DETERMINATION OF PARTICULATE MATTER IN INJECTIONS AND OPHTHALMIC SOLUTIONS | LIGHT OBSCURATION PARTICLE COUNT TEST/Instrument Standardization Tests/Particle Counting Accuracy—System Suitability | USP37–NF32 | 1301 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 26 of Method 1—MWHC Instruments: Change PB is the average particle count obtained from the suspension; to: PS is the average particle count obtained from the suspension; |
TERBINAFINE HYDROCHLORIDE | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | First Supplement to USP37–NF32 | 6704 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 2 of USP Terbinafine Related Compound A RS: Change N-Methyl-C-(naphthalen-1-yl)methanamine. to: N-Methyl-C-(naphthalen-1-yl)methanamine hydrochloride. AND Line 2 of USP Terbinafine Related Compound B RS: Change (2Z)-N,6,6-Trimethyl-… Read More |
CEFTIZOXIME FOR INJECTION | Constituted solution | USP37–NF32 | 2240 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1: Change At the time of use, it meets the requirements for Constituted Solutions under Labeling under Injections <1>. to: At the time of use, it meets the requirements for Constituted Solutions under Injections <1>. |
DOXAPRAM HYDROCHLORIDE INJECTION | ASSAY/Procedure | USP37–NF32 | 2708 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 7 of Analysis: Change RU = peak response ratio of the doxapram to the internal standard from the Sample solution RS = peak response ratio of the doxapram to the internal standard from the Sample solution to: RU… Read More |
LEFLUNOMIDE | IMPURITIES/Organic Impurities/Procedure 2 | USP37–NF32 | 3502 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 3 of Analysis: Change [Note—Disregard any peak with an area less than the leflunomide peak from the System suitability solution. to: [Note—Disregard any peak with an area less than the leflunomide peak from the Sensitivity solution. |
NALTREXONE HYDROCHLORIDE | Assay | USP37–NF32 | 3922 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 7 of Procedure: Change (377.86/341.41)10C(rU/rS) in which 377.86 and 341.41 are the molecular weights of naltrexone hydrochloride and naltrexone to: (377.86/341.40)10C(rU/r… Read More |
<551> VITAMIN E ASSAY | ASSAY/Procedure 4/Chromatographic system | First Supplement to USP37–NF32 | 6338 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1 of Flow rate: Change 1.5 mL/min to: 1 mL/min |
GENERAL NOTICES TO USP-NF | 6. TESTING PRACTICES AND PROCEDURES/6.50. Preparation of Solutions | First Supplement to USP37–NF32 | 6291 | 25-Jul-2014 | 1-Aug-2014 | USP38–NF33 | USP38–NF33 | Line 6 of 6.50.20. Solutions: Change An expression such as “(1 in 10)” means that 1 part by volume of a liquid shall be diluted with a sufficient quantity of the diluent or solvent to make the volume of the finished solution 10 parts by volume. An expression such as “(20:5:2… Read More |
SUFENTANIL CITRATE | ASSAY/Procedure/System suitability/Suitability requirements | First Supplement to USP37–NF32 | 6701 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1 of Relative standard deviation: Change NMT 0.7% to: NMT 0.73% |
BUMETANIDE | IMPURITIES | USP37–NF32 | 2024 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Row 4 of Column 1 of Table 1: Change Paroxetine butyl 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoate to: Butyl 3-(butylamino)-4-phenoxy-5-sulfamoylbenzoate |
ROPINIROLE HYDROCHLORIDE | IMPURITIES/Organic Impurities, Procedure 1/System suitability/Suitability requirements | Revision Bulletin (Official May 01, 2014) | Online | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1 of Tailing factor: Change NLT 2.0 for the ropinirole peak to: NMT 2.0 for the ropinirole peak |
CHLORDIAZEPOXIDE HYDROCHLORIDE FOR INJECTION | Constituted solution | USP37–NF32 | 2290 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1: Change At the time of use, it meets the requirements for Constituted Solutions under Labeling under Injections <1>. to: At the time of use, it meets the requirements for Constituted Solutions under Injections <1>. |
ERGOTAMINE TARTRATE | Identification | USP37–NF32 | 2826 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 4:Change value as the principal spot of Standard solution A. to: values as the corresponding spots of the Standard preparation. |
LEVOTHYROXINE SODIUM TABLETS | IMPURITIES/Organic Impurities/Procedure: Limit of Liothyronine Sodium | USP37–NF32 | 3548 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 1 of Acceptance criteria: Change NMT 2.0% of liothyronine to: NMT 2.0% of liothyronine sodium |
VITAMIN E | IDENTIFICATION/A./Sample solutions | USP37–NF32 | 5163 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Lines 4 and 7 of Alpha tocopheryl acetate: Change dilute sulfuric acid to: diluted sulfuric acid |
CEFADROXIL CAPSULES | ADDITIONAL REQUIREMENTS/USP Reference Standards <11> | First Supplement to USP37–NF32 | 6604 | 25-Jul-2014 | 1-Aug-2014 | USP39–NF34 | First Supplement to USP38–NF33 | Line 2 of USP Cefadroxil Related Compound I RS: Change (6R,7R)-7-[(R)-2-Amino-2-(4-hydroxyphenyl)acetamido]-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid monohydrate. to: (6R,7R)-7-[(R)-2-Amino-2-(4-hydroxyphenyl)acetamido… Read More |